510(k) · Cleared

Recalled · 2009

Preciset TDM I and Preciset TDM II Calibrators

K031856510(k) AbbreviatedCleared Aug 6, 200351-day reviewClass II21 CFR 862.3200Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Diagnostics Corp. · DKB Calibrators, Drug Mixture

Cleared on Aug 6, 2003 as substantially equivalent to K851032 (Roche Diagnostic Systems, Inc., 1985) and 17 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it. It has been recalled 2 times.

Decided: Aug 6, 2003
Review: 51 days
Class: Class II
Product code: DKB
Recalls: 2
Predicates: 18

Its longest line of descent runs back 2 generations to K842280 (1984). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK842280 TDX DigitoxinAbbott Laboratories · 1984
1 generation backK972250 Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1997 · Recalled
This deviceK031856 Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp. · 2003
Descendant · cites it directly · 0 of its ownK091617 QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009

Most influential descendants

Showing 1 of 1 · See all

K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K842280	TDX Digitoxin	Abbott Laboratories	1984	—
−1	K972250	Roche Cobas Integra Reagent Cassettes & Ancillary Reagents	Roche Diagnostic Systems, Inc.	1997	1
0 (this device)	K031856	Preciset TDM I and Preciset TDM II Calibrators	Roche Diagnostics Corp.	2003	—
+1	K091617	QMS Lidocaine Calibrators, Model 0374678	Thermo Fisher Scientific	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	8	0
1987	2	0
1990	1	0
1991	1	0
1992	1	0
1994	4	0
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K031856, 1984–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (18)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K851032	Cobas FP Reagents for Digoxin & Cobas FP Digoxin C Summary page 1 …ixture Classification name: Clinical Toxicology Calibrator We claim substantial equivalence to the currently marketed Roche calibrators: Cobas-FP Digoxin Calibrators, K851032 Cobas-FP Carbamazepine Calibrators, K850807 Cobas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators,…	Roche Diagnostic Systems, Inc.	1985	1
*	K850807	Cobas FP Reagents for Carbamazepine Summary page 1 …ogy Calibrator We claim substantial equivalence to the currently marketed Roche calibrators: Cobas-FP Digoxin Calibrators, K851032 Cobas-FP Carbamazepine Calibrators, K850807 Cobas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators,…	Roche Diagnostic Systems, Inc.	1985	—
*	K843827	Cobas Reagents for Gentamicin & Calibrat Summary page 1 …valence to the currently marketed Roche calibrators: Cobas-FP Digoxin Calibrators, K851032 Cobas-FP Carbamazepine Calibrators, K850807 Cobas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators,…	Roche Diagnostic Systems, Inc.	1985	—
*	K945523	Cobas (R)-FP Reagents for Gentamicin and Cobas (R)-FP Gentamicin Calibrators Summary page 1 …he currently marketed Roche calibrators: Cobas-FP Digoxin Calibrators, K851032 Cobas-FP Carbamazepine Calibrators, K850807 Cobas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators, K852318 Co…	Roche Diagnostic Systems, Inc.	1995	—
*	K936131	Cobas-FP Reagent for Phenytoin and Coba-FP Phenytoin Calibrators Summary page 1 …Cobas-FP Digoxin Calibrators, K851032 Cobas-FP Carbamazepine Calibrators, K850807 Cobas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators, K852318 Cobas-FP Theophylline Calibrators, K871484…	Roche Diagnostic Systems, Inc.	1994	—
*	K936130	Cobas-FP Reagent for Phenobarbital and Cobas-FP Phenobarbital Calibrators Summary page 1 …s-FP Carbamazepine Calibrators, K850807 Cobas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators, K852318 Cobas-FP Theophylline Calibrators, K871484 Cobas-FP Tobramycin Calibrators, K843828 C…	Roche Diagnostic Systems, Inc.	1994	—
*	K852318	Cobas FP Reagen for Primidone & Primi Calibrators Summary page 1 …obas-FP Gentamicin Calibrators, K843827 and K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators, K852318 Cobas-FP Theophylline Calibrators, K871484 Cobas-FP Tobramycin Calibrators, K843828 Cobas-FP Valproic Acid Calibrators, K92500…	Roche Diagnostic Systems, Inc.	1985	—
*	K871484	Cobas FP Reagents for Theophylline & Calibrators Summary page 1 …K945523 Cobas-FP Phenytoin Calibrators, K936131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators, K852318 Cobas-FP Theophylline Calibrators, K871484 Cobas-FP Tobramycin Calibrators, K843828 Cobas-FP Valproic Acid Calibrators, K925003 Cobas-FP Vancomycin Calibrators, K901759…	Roche Diagnostic Systems, Inc.	1987	—
*	K843828	Cobas Reagents for Tobramycin & Calibra Summary page 1 …36131 Cobas-FP Phenobarbital Calibrators, K936130 Cobas-FP Primidone Calibrators, K852318 Cobas-FP Theophylline Calibrators, K871484 Cobas-FP Tobramycin Calibrators, K843828 Cobas-FP Valproic Acid Calibrators, K925003 Cobas-FP Vancomycin Calibrators, K901759 Roche TDM ONLINE Digitoxin Calibrators, K…	Roche Diagnostic Systems, Inc.	1985	—
*	K925003	Cobas-FP Reagent for Valproic Acid and Calibrators Summary page 1 …36130 Cobas-FP Primidone Calibrators, K852318 Cobas-FP Theophylline Calibrators, K871484 Cobas-FP Tobramycin Calibrators, K843828 Cobas-FP Valproic Acid Calibrators, K925003 Cobas-FP Vancomycin Calibrators, K901759 Roche TDM ONLINE Digitoxin Calibrators, K972250 Cobas-FP Amikacin Calibrators, K852317…	Roche Diagnostic Systems, Inc.	1992	—
*	K901759	Cobas-FP Reagents for Vancomycin Summary page 1 …2318 Cobas-FP Theophylline Calibrators, K871484 Cobas-FP Tobramycin Calibrators, K843828 Cobas-FP Valproic Acid Calibrators, K925003 Cobas-FP Vancomycin Calibrators, K901759 Roche TDM ONLINE Digitoxin Calibrators, K972250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010…	Roche Diagnostic Systems, Inc.	1990	—
*	K972250	Roche Cobas Integra Reagent Cassettes & Ancillary Reagents Summary page 1 …Cobas-FP Tobramycin Calibrators, K843828 Cobas-FP Valproic Acid Calibrators, K925003 Cobas-FP Vancomycin Calibrators, K901759 Roche TDM ONLINE Digitoxin Calibrators, K972250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Pro…	Roche Diagnostic Systems, Inc.	1997	1
*	K852317	Cobas FP Reagen for Amikacin & Amikacin Calibrator Summary page 1 …28 Cobas-FP Valproic Acid Calibrators, K925003 Cobas-FP Vancomycin Calibrators, K901759 Roche TDM ONLINE Digitoxin Calibrators, K972250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Procainamide Calibrators, K852320 and K942…	Roche Diagnostic Systems, Inc.	1985	—
*	K853010	Cobas Reagent for Lidocaine & Calibrators Summary page 1 …925003 Cobas-FP Vancomycin Calibrators, K901759 Roche TDM ONLINE Digitoxin Calibrators, K972250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 Cobas-FP Quinidine Calibrators, K9…	Roche Diagnostic Systems, Inc.	1985	—
*	K871680	Modified Cobas FP Reagents for Napa and Calibrator Summary page 1 …ors, K901759 Roche TDM ONLINE Digitoxin Calibrators, K972250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 Cobas-FP Quinidine Calibrators, K941440 Continued on next page 24 =…	Roche Diagnostic Systems, Inc.	1987	—
*	K852320	Cobas FP Reagen for Procainamide & Pro Calibrator Summary page 1 …ibrators, K972250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 Cobas-FP Quinidine Calibrators, K941440 Continued on next page 24 51O(k) Summaw, Continued 4)…	Roche Diagnostic Systems, Inc.	1985	—
*	K942847	Cobas (R)-FP Reagent for Procainamide/Calibrator Summary page 1 …72250 Cobas-FP Amikacin Calibrators, K852317 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 Cobas-FP Quinidine Calibrators, K941440 Continued on next page 24 51O(k) Summaw, Continued 4) Device R…	Roche Diagnostic Systems, Inc.	1994	—
*	K941440	Cobas-FP Quinidine Reagents and Calibrators Summary page 1 …7 Cobas-FP Lidocaine Calibrators, K853010 Cobas-FP NAPA Calibrators, K871680 Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 Cobas-FP Quinidine Calibrators, K941440 Continued on next page 24 51O(k) Summaw, Continued 4) Device Roche Preciset TDM I calibrators contain a m…	Roche Diagnostic Systems, Inc.	1994	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091617	QMS Lidocaine Calibrators, Model 0374678	Thermo Fisher Scientific	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 22, 2009	Not classified	Z-2001-2009	Packaging process control	The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
Apr 22, 2009	Not classified	Z-2000-2009	Packaging process control	The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
3 of the 21 ancestors have a recall of any class.
Of its descendants, K091617 (Thermo Fisher Scientific, 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKB

2in 2014

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

Too few DKB 510(k)s in any year since 2007 to give a median.

Recalls per year · DKB

2in 2022

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DKB

1in 2017

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	2	—	3	0
2010	0	—	0	0
2011	2	—	2	1
2012	1	—	1	4
2013	0	—	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	2	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Preciset TDM I calibrators are designed for the calibration of the Roche assays for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, phenobarbital, primidone, theophylline, tobramycin, valproic acid and vancomycin in human serum and plasma on automated clinical chemistry analyzers.

The Preciset TDM II calibrators are designed for the calibration of the Roche assays for the quantitative determination of digitoxin, amikacin, lidocaine, N-acetylprocainamide, procainamide and quinidine in human serum and plasma on automated clinical chemistry analyzers.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K031856 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031856: Preciset TDM I and Preciset TDM II Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031856

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026